Compliance Manager

3 weeks ago


Cape Town, South Africa YAM Recruitment Full time

**COMPLIANCE MANAGER**

**MAIN PURPOSE**:

- Develop, implement and maintain a sustainable Quality Management System (QMS) that complies with the mandatory requirements of SAHPRA.

**JOB OBJECTIVES**:

- Ensure good manufacturing practice (GMP) compliance in accordance with Act 101 and SAHPRA requirements.
- Develop and maintain organizations Quality Management System (QMS).
- Assist with local and international audits.
- Ensure adherence to internal and external audit schedules.
- Promote a risk management approach within the company.
- Review and approve deviations from manufacturing, packing and distribution sites, as applicable.
- Review and approve change controls from manufacturing, packing and distribution sites, as applicable.
- Manage the corrective and preventative actions register to ensure timeous completion of actions.
- Maintain all registers and trending records of the QMS.
- Prepare the QMS performance data.
- Schedule periodic management review meetings and manage the completion of any actions originating from these meetings.
- Ensure compliance with validation program.
- Ensure compliance with the annual product review schedule.
- Ensure compliance with the stability program.
- Manage the standard operating procedures (SOPs) matrix.
- Prepare and promote GMP training.
- Manage the training matrix.
- Investigate any product or customer compliant relating to quality issues.
- Manage the change control procedure system.
- Ensure the business remains complaint with all legal and regulatory requirements.
- Manage reporting staff.
- Assist with any other duties as per operational requirements within the QA department.

**JOB REQUIREMENTS**:
**Job Knowledge**:

- SAHPRA, ICH and PICs GMP guidelines (Essential).
- SAHPRA, ICH and PICs GMP quality assurance requirements and practices (Essential).
- International PICs Auditing requirements (Essential).
- Good documentation practice (Essential).
- Development of training modules.
- Staff training.

**Job Related Skills**:

- Computer literacy with the ability to effectively use Excel, Word and PowerPoint.
- Auditing skills.
- Communication skills, both verbal and effective writing.
- Analytical and problem-solving skills.
- Training and Presentation skills.
- Planning and Organising skills.
- Verbal and written communication skills.
- Management and supervisory skills.
- Relationship building skills.

**Job Experience**:

- At least 5 years quality assurance experience.
- At least 5 years working experience in a pharmaceutical QA environment.
- Computer literacy with the ability to effectively use Excel, Word and PowerPoint.
- Preferable: history of effectively managing reportees.

**Education**:
**Essential**:

- B. Pharm Degree or a suitable Scientific or Life Sciences Degree

**Desirable**:

- Course in GMP / Quality Assurance
- Course in Document Management / Document integrity

**Essential Competencies**:

- Computer literacy.
- Deciding and initiating action.
- Working with people.
- Relating and networking.
- Analytical thinking.
- Good attention to detail.
- Planning and organising.
- Coping with pressures and setbacks.
- Leadership and supervisory skills.
- High accuracy with thorough attention to detail.


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